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The primary objective is to evaluate the antitumor efficacy of lazertinib in patients with NSCLC harboring uncommon EGFR mutations. The primary endpoint is objective response rate (ORR), defined as the proportion of patients achieving a complete response or partial response per RECIST v1.1 by investigator's assessments.Secondary endpoints are disease control rate, progression-free survival, overall survival, and duration of response. Secondary objectives are progression-free survival, overall survival, and safety profile according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Lazertinib 240mg daily (1 cycle of 21 days) will be applied to the all patients until documented evidence of disease progression, unacceptable toxicity, noncompliance, or withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first. However, beyond disease progression is allowed based on the investigator's decision. Doses should be taken approximately 24 hours apart at the same time point each day before eating meal under fasting. If it is more than 12 hours after the dose time, the missed dose should not be taken, and patients should be instructed to take the next dose at the next scheduled time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lazertinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lazertinib | Drug | Lazertinib 240mg daily (1 cycle of 21 days) will be applied to the all patients until documented evidence of disease progression, unacceptable toxicity, noncompliance, or withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first. However, beyond disease progression is allowed based on the investigator's decision. Doses should be taken approximately 24 hours apart at the same time point each day before eating meal under fasting. If it is more than 12 hours after the dose time, the missed dose should not be taken, and patients should be instructed to take the next dose at the next scheduled time. |
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate (ORR) | It is evaluated by taking CT of the chest and abdomen (including liver and adrenal glands) or MRI . | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival(PFS) | PFS is measured from the date of start of study to the date of disease progression or death from any cause. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
Previously treatment with any kind of EGFR TKI
Uncontrolled central nervous system metastases
Leptomeningeal carcinomatosis
Uncontrolled systemic illness, including uncontrolled hypertension, active bleeding, or active infection
Cytotoxic chemotherapy, investigational agents or other anticancer drugs within 14days of first dose of study treatment, or any investigational drugs within 5 x half-lives of the compound
Major surgery undertaken less than 4 weeks before the study
Localized palliative radiotherapy unless completed more than 2 weeks before the study
Pregnant or nursing women (Women of reproductive potential have to agree to use an effective contraceptive method, contraception until 3 months after discontinuation of drug for female, hormonal methods should be used in combination with barrier methods)
Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer, early gastric cancer or otherwise confirmed as curative malignancy disease by principal investigator
Any of the following cardiac criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MinHee Hong | Contact | 82-2-2228-8129 | MINHEE_HONG@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| MinHee Hong | Yonsei University Health System, Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Severance Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40350080 | Derived | Park S, Ahn HK, Lee S, Min YJ, Kim J, Jung HA, Sun JM, Lee SH, Ahn JS, Ahn MJ, Lee JB, Lim SM, Kim HR, Cho BC, Hong MH. Lazertinib for Patients with NSCLC Harboring Uncommon EGFR Mutations: A Phase II Multicenter Trial. J Thorac Oncol. 2025 Sep;20(9):1279-1288. doi: 10.1016/j.jtho.2025.05.006. Epub 2025 May 9. |
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| ID | Term |
|---|---|
| C000707992 | lazertinib |
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|
OS is measured from the date of start of study to the date of death from any cause. |
| From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Safety and toxicity profile evaluated throughout the study participation period. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |